The current practice necessitites the use of a needle through a self sealing rubber stopper. This is demonstrated in the Click Lock.TM. I.V. system manufactured by ICU Medical, Inc. which can be used with either a heparin lock or a multilumen central line. (See I.V. Therapy, Nursing, May 1989, pg. 50). The Click Lock.TM. intravenous (I.V.) system has two components: a transparent housing that contains a recessed needle and a diaphragm-covered port that fits into the needle housing. A locking device on the needle housing then clicks over a flange at the base of the port, securing the components as the needle pierces the diaphragm. The Click Lock.TM. I.V. system can be used to piggyback an I.V. into regular I.V. tubing, a heparin lock, or a central line.
Use of the Click Lock.TM. I.V. system with a heparin lock is shown in FIG. 7, attached hereto, wherein a needle 50 contained within housing 52 is typically injected into a rubber diaphragm injection port 54. A locking device 60 disposed on housing 52 clicks over a flange 62 at the base of injection port 54. Thereafter, injection port 54 is connect to a luer lock device 56 by means of I.V. tubing 58. Luer lock device 56 can thereafter be connected to a catheter, not shown.
Some other examples demonstrating the use of needles at I.V. injection units are U.S. Pat. Nos. 4,121,585 (Becker, Jr.), issued Oct. 24, 1978, 4,585,435 (Vaillancourt), issued Apr. 29, 1986, and 4,596,557 (Pexa), issued Jun. 24, 1986.
The health risk associated with needle sticks has become of great concern to the medical community. This is evidenced by the recently published article, "Despite Safety Guidelines, Various Devices Still Cause Needle-Stick Injuries," Oncology Nurse Bulletin, (NCM Publishers, Inc.), Oct. 1988, pp. 2 and 8. This article discusses the complacency about needle sticks which causes approximately 300 healthcare workers to die each year from direct or indirect consequences of occupational acquired hepatitis B, not to mention the number which test positive each year to AIDS testing. The article continues to state that "the second most common cause of needle sticks, and the biggest rate of injury, came from accidents involving intravenous tubing needle assemblies". In these accidents, over one quarter were related to recapping, and this was probably due to the fact that the needle caps were unavailable when intravenous lines were dismantled. The needle sticks occurred when alternative methods, such as introducing needles into drip chambers, intravenous ports or bags, were used for covering the needles.
Thus, needle sticks can occur from recapping of needles, poor needle connections, attempts at removal of a needle by loosening of the needle hub from the tubing, and when the needle is either manually or accidental dislodged from the tubing.
Any injury from a used needle is potential for infection, especially hepatitis B and AIDS. Conventional infusion ports typically include a polyvinylchloride primary infusion tubing, an infusion port, and self sealing rubber stopper. During administration of a medication or other solutions a needle is injected into self sealing rubber stopper located about the opening of the infusion port.
Needle sticks occur during the injection and withdrawal of the needle from the stopper, and at most anytime when the needle is uncapped, transported or disposed. Since intravenous injections are common place in medical treatment, it is entirely to risky to continue to expose medical personnel to needle sticks which can lead to the contraction of infectious diseases.
The present inventor has developed a unique bi-directional valve assembly which does not require the use of needles to deliver a transfusional or perfusional liquid, a nourishing solution, a vitamin solution, a medicinal solution, an anticoagulant solution or a like solution, to infusion systems (e.g., I.V. systems), thereby completely eliminating the threat of contracting infectious diseases when the solution is administered via the system. It also prevents escape of contaminated blood or other bodily fluids through, for example, an I.V. tubing, thus further reducing the risk to healthcare professionals.
One device which attempts to eliminate the use of needles during the administration of secondary medications or blood transfusions to a Y-shaped injection unit of an I.V. system is set forth in U.S. Pat. No. 3,994,293 (Ferro), issued Nov. 30, 1976. The Ferro patent describes an injection assembly which can be used in combination with a feeding means (e.g., a syringe) for infusing a transfusional or perfusional liquid, a nourishing solution, a vitamin solution, a medicinal solution, an anticoagulant solution or a like solution, wherein penetration of a hollow piercing member (e.g., a syringe needle) into the injector body is not necessary. The purpose of the device set forth in the Ferro patent is to overcome the disadvantages caused by repeatedly injecting new needles into the injector wall. That is, after repeated injections the injector wall weakens and is no longer adequately sealed.
The Ferro patent makes use of a liquid pressure-actuated elastomeric diaphragm positioned in the tubular branch portion. The diaphragm includes a pre-perforated portion formed having a pressure threshold corresponding to a predetermined pressure of the solution upstream of the diaphragm. The pre-perforated portion is normally impervious to prevent passage of the solution through the tubular branch portion of the tubular conduit portion when the pressure of the solution upstream of the diaphragm is less than the pressure threshold. The pre-perforated portion becomes pervious to allow passage of the solution through the tubular branch portion to the tubular conduit portion when the pressure of the solution upstream of the diaphragm is at least equal to or greater than the pressure threshold. Furthermore, a valve means cooperating with the pre-perforated portion of the diaphragm only permits unidirectional feeding of the solution in the tubular portion through the pre-perforated portion to the tubular conduit portion, but not vice versa.
One disadvantage of the injector assembly set forth in the Ferro patent is that it causes air in the tubing and does not permit bi-directional movement of the pre-perforated portion of the diaphragm.
The Safsite.TM. reflux valve manufactured by B. Braun is similar to the Ferro patent in that it replaces injection stoppers with a needless reflux valve. This reflux valve includes a flexible diaphragm which is opened by standard luer taper permitting injection, gravity flow or withdrawal of fluids. Reflux valves can be used for piggy-back administration or for accessing a multi-lumen catheter or central line, peripheral line or heparin lock. (See U.S. Pat. No. 4,535,820 (Raines), which issued on Aug. 20, 1985).
Various needleless syringe assemblies have been designed for use in catheter devices, e.g., U.S. Pat. Nos. 4,752,287 (Kurtz et al.), issued Jun. 21, 1988, 4,816,020 (Brownell), issued Mar. 28, 1989, and 4,333,455 (Bodicky), issued Jun. 8, 1982. These devices are concerned with inflation of catheter ballons and not the injection of medicines or other solutions into an intravenous system.
The present invention overcomes the aforementioned disadvantages of conventional infusion systems by providing a device which eliminates the use of needles and injection port stoppers in the administration of a transfusional or perfusional liquid, a nourishing solution, a vitamin solution, a medicinal solution, an anticoagulant solution or a like solution, via an injection port. The present invention also completely eliminates the risk of contracting an infectious disease due to needle sticks during the handling of infusion systems.
The present invention accomplishes the aforementioned advantages by positioning a novel two-way spring valve within intravenous tubing, valve infusion port locks (e.g., saline or heparin locks), multilumen catheter or central lines, peripheral lines, and piggy-back administration systems to permit administration of a transfusional or perfusional liquid, a nourishing solution, a vitamin solution, a medicinal solution, an anticoagulant solution or a like solution without the injection of a needle and permits bi-directional movement of the valve to avoid backflow of solution or air contamination of the infusion system. This unique bi-directional valve assembly can also be used in nasogastric tubing and percutaneous endogastric tubing to enable the periodic removal of bodily fluids while preventing unimpeded discharge thereof.
Additional advantages of the present invention shall become apparent as described below.